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Government and industry stakeholders at a public workshop on health IT found plenty of agreement, but few concrete proposals for a path forward. Read More
CINCINNATI — Only devices that violate the 1938 FD&C Act should be labeled Import for Export, FDA officials cautioned at the recent FDA/Xavier University MedCon conference. Read More
A chief architect of a 2007 law promoting the development of medical devices for children has asked the FDA to provide evidence it is making progress on meeting its goals. Read More
San Diego devicemaker Dr. Joel Kaplan, Inc., received an FDA warning letter for off-label claims about its penis pumps, including advertising the devices online to fix penile curvature. Read More
Devicemakers often misuse voluntary consensus standards in premarket submissions, the FDA says, by using versions of standards that the agency doesn’t recognize or using consensus standards that don’t apply to their specific device or testing methods. Read More